Stryker Orthopedics Announces Voluntary Recall

July 19, 2012, 8:00AM. By Heidi Turner

Kalamazoo, MIStryker Orthopedics announced it is recalling certain hip replacement components due to concerns about corrosion in the products. Earlier this month, the company announced a Rejuvenate Modular-Neck Stems recall along with a recall of the ABG II modular-neck stems. The modular-neck stems are used in hip implants and have been linked to reports of adverse events.

According to Stryker Orthopedics, the voluntary recall was announced because of potential risks associated with the modular-neck stems (found at www.aboutstryker.com/modularneckstems). "These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling."

Stryker notes that the incidence of complications is low, and patients who do not notice symptoms of fretting or corrosion should follow their post-operative plan as normal. Patients who experience pain and/or swelling in or near their replaced hip are encouraged to speak with their surgeon to discuss their options. Patients who are not sure whether they have a recalled device implanted can obtain that information by phoning their surgeon.

According to a press release issued by Stryker (found online at www.fda.gov; 7/6/12), the recall affects global distribution of the Rejuvenate and ABG II modular-neck stems. "Following this action, we will work with the medical community to better understand this matter as we continue to evaluate this data," said Stuart Simpson, vice president and general manager, hip reconstruction.

On May 28, 2012, Health Canada announced that the Stryker Rejuvenate was being recalled to allow the instructions for use to be updated. That recall affected only devices sold in Canada and did not occur in the US.